CMS Reverses Proposed Expansion of Carotid Stenting Coverage

BY MARY ELLEN SCHNEIDER

Officials at the Centers for Medicare and Medicaid Services have reversed a proposal to expand coverage for carotid artery stenting in asymptomatic patients

Instead, Medicare will continue to cover percutaneous transluminal angioplasty of the carotid artery concurrent with stenting, mainly in patients who are at high risk for carotid endarterectomy (CEA) and who also have symptomatic carotid artery stenosis of 70% or greater.

Medicare also will continue to cover the procedure in patients at high risk for CEA with symptomatic carotid artery stenosis between 50% and 70% in Category B Investigational Device Exemption (IDE) trials and in postapproval studies. The procedure will be covered only in asymptomatic patients under limited circumstances. Medicare will cover patients who are at high risk for CEA and have asymptomatic carotid artery stenosis of 80% or greater as part of a Category B IDE trial or a postapproval study.

The proposed decision to expand coverage of carotid artery stenting in asymptomatic patients outside of the protection of clinical trials and postapproval studies was "premature," CMS said in its decision memo. However, officials also noted that registry and postapproval studies show a trend toward improving outcomes, and so they have continued coverage for patients who are enrolled in clinical trials or are part of postapproval studies.

Reversals of CMS-proposed coverage decisions have happened in the past, but they are not common, a CMS spokesman said.

The policy reversal means that the agency will not proceed with plans to restrict coverage for patients 80 years of age or older to clinical trials and postapproval studies. And CMS also will not go forward with its proposal to require a surgeon to perform a consultation to ascertain a patient's high-risk status before undergoing carotid artery stenting.

Although CMS has rolled back most of the provisions of its February 2007 carotid artery stenting proposal, some aspects will remain in place. For example, CMS plans to implement the clarifications regarding the use of embolic protection devices and the facility certification and recertification process. Under the coverage decision, carotid artery stenting is covered only when used with an embolic protection device. The procedure will not be covered if the deployment of the distal embolic protection device is not possible.

The coverage decision reversal is good news in the eyes of many, including the neurology community, who had urged CMS officials to be cautious in expanding coverage in this area. Both the American Academy of Neurology and the American Association of Neurological Surgeons submitted comments to CMS in which they said that the available evidence did not warrant expansion, and noted that the CMS proposal was based on case series data and company registries, which can be biased and are not helpful in determining efficacy.

Efforts to expand coverage now would make the development and completion of a randomized trial comparing CEA, carotid artery stenting, and medical therapy difficult, if not impossible, the American Stroke Association said in comments to CMS.

In the last issue of VASCULAR SPECIALIST in the cover story on the proposed expansion, Dr. Robert Zwolak, chair of the health policy committe of the Sociey for Vascular Surgery pointed out the society'sposition, stating "SVS does not support expansion to cover asymptomatic patients with so-called physiologic high-risk factors because the 30-day event rates of CAS (mostly strokes) in the largest studies remain in the 5%-7%range."

Other professional medical societies that represent cardiologists supported the proposed coverage expansion. In comments to CMS, the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions supported efforts to expand carotid artery stenting to asymptomatic patients at high risk for CEA.

The expansion of coverage was formally requested in March 2006 by Abbott Laboratories, which manufactures two carotid artery stent products, based on new evidence, including four Abbott-sponsored studies.

"This is a disappointing decision for carotid artery disease patients who are at high risk for surgery and who don't have symptoms of stroke," the company said in a statement. "However, these patients will still have access to carotid artery stenting as a treatment option if they are enrolled in FDA-approved postmarketing clinical trials."